This multicenter, open-label, phase Ib trial aims to assess the safety and activity and safety of crizotinib (in combination with radiotherapy and temozolomide) in adult patients with newly diagnosed glioblastoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Crizotinib is added to Stupp method
Institut Català D'Oncologia L'Hospitalet (Ico)
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Del Mar
Barcelona, Spain
Hospital Clínic de Barcelona
Barcelona, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Treatment safety
Number of participants with adverse events as a measure of safety and tolerability
Time frame: 7 months
Recommended dose in phase II
Based on pharmakinetic analysis by Cmax
Time frame: 7 months
Anti-tumor activity
Time frame: 7 months
Overall Survival
Time between start of treatment and death
Time frame: Two years
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